Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery (NCT00002807) | Clinical Trial Compass
CompletedNot Applicable
Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
United States, Australia, Canada116 participantsStarted 1996-07-04
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.
Who can participate
Age range
120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium
* Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy
* Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades)
* Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible
* Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible
* No pathologically involved lymph nodes if staging procedure performed
* Stage I papillary serous or clear cell endometrial cancer allowed
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-3
Life expectancy:
* At least 3 years
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Not specified
Renal:
* Creatinine less than 2 times upper limit of normal
* No serious renal disease that would preclude radiotherapy
Cardiovascular:
* No serious cardiovascular disease that would preclude radiotherapy
Other:
* No history of inflammatory bowel disease such as ulcerative colitis
* No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.